CRC Foundations - Site Management,
Quality Assurance, and Public
Information questions with answers.
Identify facility-associated challenges related to maintaining compliance with Good Clinical Practice
(GCP) standards at a clinical research site. ANS -
Describe the facility and educational requirements for point-of-care testing as well as basic blood
processing and shipping capabilities at a clinical research site. ANS -
Describe the components of an effective quality assurance program for a clinical research site. ANS -
Detect the difference between unintentional protocol deviations and scientific misconduct in a clinical
trial. ANS -
Recognize the importance of establishing mentoring and working relationships in the workplace. ANS -
Describe acceptable ways to share clinical trial information with the scientific community and the public.
ANS -
A quality assurance program should include:
A) Policies and procedures, training, audits, and corrective action plans
B) Testing CRCs on knowledge of GCP
C) Discipline for CRCs for protocol deviations
D) Training PIs to enter the study data into an EDC system ANS - Policies and procedures, training,
audits, and corrective action plans
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